Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00646542
First received: March 24, 2008
Last updated: January 3, 2013
Last verified: January 2013
  Purpose
This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency. [ Time Frame: 24 weeks ]
  • To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency. [ Time Frame: 24 weeks ]

Enrollment: 525
Study Start Date: March 2005
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Vildagliptin
Other Name: Galvus
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History T2DM
  • Moderate or Severe Renal Impairment

Exclusion Criteria:

  • Glucose > 270 mg/dL (>15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646542

Locations
Argentina
Buenos Aires, Argentina
Australia
Heidelberg Heights, Australia
Canada
Winnipeg, Canada
Costa Rica
Cartago, Costa Rica
Finland
Tampere, Finland
France
Angers, France
Germany
Dormagen, Germany
India
Chennai, India
Norway
Oslo, Norway
Russian Federation
Saint Petersburg, Russian Federation
Spain
Alicante, Spain
Sweden
Lund, Sweden
Sponsors and Collaborators
Novartis
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00646542     History of Changes
Other Study ID Numbers: CLAF237A23137 
Study First Received: March 24, 2008
Last Updated: January 3, 2013

Keywords provided by Novartis:
Type 2 diabetes, vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 19, 2017